Hematinic Plus Tablets
WARNING: Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away. @ COMMON USES: It is used to help growth and good health.It may be given to you for other reasons. Talk with the doctor.It is used to treat or prevent low iron in the body.
Drug Class
Nutritional Supplement, Antianemic Agent
Pharmacologic Class
Vitamins (Water-soluble), Minerals (Iron), Hematopoietic Agents
Pregnancy Category
Category A/B (depending on specific vitamin/mineral doses and indication)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hematinic Plus Tablets are a combination of iron and B vitamins. Iron is essential for making red blood cells that carry oxygen throughout your body. B vitamins help your body use energy from food and are also important for healthy red blood cells and nerve function. This supplement helps prevent or treat deficiencies of these important nutrients, especially if you have anemia.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Protect it from heat and light to prevent degradation. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or overdose.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of adverse effects.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Protect it from heat and light to prevent degradation. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or overdose.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Take with a full glass of water.
- For best absorption, take iron on an empty stomach (1 hour before or 2 hours after meals). However, if stomach upset occurs, take with food (avoiding dairy, tea, coffee, and high-fiber foods).
- Avoid taking iron supplements with milk, tea, coffee, or antacids, as these can reduce iron absorption. Separate by at least 2 hours.
- Vitamin C (ascorbic acid) can enhance iron absorption; consider taking with orange juice or a Vitamin C supplement.
- Maintain a balanced diet rich in iron (red meat, poultry, fish, beans, fortified cereals) and B vitamins (whole grains, leafy greens, dairy, meat).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Typical daily dose varies by specific product formulation. For iron deficiency anemia, elemental iron 60-100 mg daily, often divided. B vitamins typically at or above Recommended Daily Allowance (RDA).
Condition-Specific Dosing:
Iron Deficiency Anemia:
Elemental iron 60-100 mg daily, often divided into 1-3 doses. B vitamins (e.g., B12 1000 mcg, Folic Acid 1 mg) as needed for specific deficiencies.
Pediatric Dosing
Neonatal:
Not established (specific pediatric formulations and dosing required, consult pediatrician)
Infant:
Not established (specific pediatric formulations and dosing required, consult pediatrician)
Child:
Dosing varies significantly by age, weight, and specific deficiency. Elemental iron 3-6 mg/kg/day for iron deficiency anemia, divided into 1-3 doses. B vitamin doses are age-dependent. Consult pediatrician.
Adolescent:
Similar to adult dosing for iron deficiency (e.g., 60-100 mg elemental iron daily) and B vitamins, adjusted for weight and specific needs.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required for standard supplement doses.
Moderate:
No specific adjustment typically required for standard supplement doses. Monitor iron levels if high doses are used.
Severe:
Use with caution. Iron accumulation can occur in patients on dialysis or with severe renal impairment. B vitamin excretion may be altered, but generally safe at supplement doses. Consult nephrologist.
Dialysis:
Iron supplementation is often required for patients on dialysis due to increased losses and erythropoietin stimulating agent (ESA) therapy. Dosing should be guided by iron studies and physician. B vitamins are generally safe.
Hepatic Impairment:
Mild:
No specific adjustment typically required.
Moderate:
No specific adjustment typically required. Monitor iron levels if high doses are used, as iron metabolism can be affected.
Severe:
Use with caution. Iron overload can exacerbate liver disease. B vitamin metabolism may be altered, but generally safe at supplement doses. Consult hepatologist.
Pharmacology
Mechanism of Action
Hematinic Plus Tablets provide essential micronutrients necessary for erythropoiesis (red blood cell formation) and overall metabolic function. Iron is a crucial component of hemoglobin, myoglobin, and various enzymes, vital for oxygen transport and cellular respiration. B vitamins, including B1 (thiamine), B2 (riboflavin), B3 (niacin), B5 (pantothenic acid), B6 (pyridoxine), B7 (biotin), B9 (folic acid), and B12 (cobalamin), act as coenzymes in numerous metabolic pathways. Folic acid and B12 are particularly critical for DNA synthesis and red blood cell maturation, preventing megaloblastic anemia. Other B vitamins support energy metabolism, nerve function, and cell growth.
Pharmacokinetics
Absorption:
Bioavailability:
Iron: Varies significantly (5-35%) depending on iron status, form of iron, and dietary factors. B vitamins: Generally well-absorbed from the small intestine, but varies by specific vitamin (e.g., B12 requires intrinsic factor).
Tmax:
Iron: 2-4 hours (for peak serum iron). B vitamins: Varies, generally within 1-4 hours.
FoodEffect:
Iron: Absorption is reduced by food, especially dairy, tea, coffee, and high-fiber foods. Ascorbic acid (Vitamin C) enhances iron absorption. B vitamins: Generally well-absorbed with or without food, though some (e.g., B12) may be better absorbed with food.
Distribution:
Vd:
Not specifically defined for combination products; individual components distribute widely throughout body tissues.
ProteinBinding:
Iron: Primarily bound to transferrin in plasma. B vitamins: Varies; some are protein-bound (e.g., B12 to transcobalamins), others are free.
CnssPenetration:
Limited for iron (regulated transport). Yes for most B vitamins (cross blood-brain barrier).
Elimination:
HalfLife:
Iron: Not applicable (recycled). B vitamins: Varies widely (e.g., B12 has a long half-life due to enterohepatic recirculation and storage; other water-soluble vitamins have shorter half-lives, hours to days).
Clearance:
Iron: Primarily through fecal excretion of unabsorbed iron; minimal urinary excretion. B vitamins: Primarily renal excretion of excess or metabolized forms.
ExcretionRoute:
Iron: Fecal (unabsorbed), minimal urinary. B vitamins: Renal (urine).
Unchanged:
Iron: Not applicable. B vitamins: Significant amounts of unutilized water-soluble vitamins are excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Not acutely defined for nutritional supplements. Clinical effects (e.g., improvement in anemia) are gradual, typically weeks to months.
PeakEffect:
Not acutely defined. Sustained effect with consistent daily use.
DurationOfAction:
Sustained with daily supplementation; body stores of iron and some B vitamins (e.g., B12) can last for extended periods if supplementation is stopped.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Black, tarry, or bloody stools
- Fever
- Vomiting blood or material that looks like coffee grounds
- Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
- Stomach pain or diarrhea
- Upset stomach or vomiting
- Decreased appetite
- Gas
- Bad taste in your mouth
- Constipation
- Change in stool color to green
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Black, tarry, or bloody stools
- Fever
- Vomiting blood or material that looks like coffee grounds
- Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
- Stomach pain or diarrhea
- Upset stomach or vomiting
- Decreased appetite
- Gas
- Bad taste in your mouth
- Constipation
- Change in stool color to green
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain, nausea, vomiting, or diarrhea (especially if bloody or tarry)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual fatigue, weakness, or pallor (if symptoms worsen despite treatment)
- Dark, tarry stools (may indicate gastrointestinal bleeding, though black stools are common with iron and usually harmless)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking levodopa.
If you have an iron overload in your body.
If you have certain types of anemia, including pernicious anemia or hemolytic anemia.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues you may have. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so with your specific health conditions and medications.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking levodopa.
If you have an iron overload in your body.
If you have certain types of anemia, including pernicious anemia or hemolytic anemia.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues you may have. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so with your specific health conditions and medications.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and laboratory personnel that you are taking it.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor before taking this medication, as some products may contain this ingredient. Regular blood tests will be necessary to monitor your condition, as directed by your doctor.
Taking this medication may affect the absorption of other oral medications. If you are taking other drugs by mouth, your doctor may advise you to take them at a different time than this medication to ensure proper absorption.
Not all formulations of this medication are suitable for children, so it is crucial to discuss this with your doctor if you are considering giving it to a child. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, you must consult with your doctor to weigh the benefits and risks of this medication to both you and your baby.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor before taking this medication, as some products may contain this ingredient. Regular blood tests will be necessary to monitor your condition, as directed by your doctor.
Taking this medication may affect the absorption of other oral medications. If you are taking other drugs by mouth, your doctor may advise you to take them at a different time than this medication to ensure proper absorption.
Not all formulations of this medication are suitable for children, so it is crucial to discuss this with your doctor if you are considering giving it to a child. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, you must consult with your doctor to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe abdominal pain
- Nausea, vomiting (may be bloody)
- Diarrhea (may be bloody)
- Drowsiness, lethargy
- Pale, clammy skin
- Rapid, weak pulse
- Low blood pressure
- Bluish discoloration of lips and fingernails
- Seizures
- Coma
- Liver damage (delayed)
What to Do:
Iron overdose is a medical emergency, especially in children. Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222) immediately. Do NOT induce vomiting unless instructed by medical personnel.
Drug Interactions
Major Interactions
- Levodopa (with high doses of pyridoxine/Vitamin B6, unless carbidopa is also given)
- Tetracyclines (e.g., doxycycline, minocycline) - Iron forms insoluble chelates, reducing absorption of both.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - Iron forms insoluble chelates, reducing absorption of both.
- Levothyroxine - Iron can impair absorption of levothyroxine.
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide) - Reduce iron absorption.
- H2-receptor antagonists (e.g., ranitidine, famotidine) - Reduce iron absorption.
- Proton pump inhibitors (e.g., omeprazole, pantoprazole) - Reduce iron absorption.
- Bisphosphonates (e.g., alendronate) - Iron can reduce bisphosphonate absorption.
- Mycophenolate mofetil - Iron can reduce mycophenolate absorption.
- Chloramphenicol - Can interfere with iron utilization and B12 response.
- Colchicine - Can impair B12 absorption.
- Metformin - Can reduce B12 absorption.
- Phenytoin, Phenobarbital, Primidone - Can increase folate metabolism, potentially leading to folate deficiency.
- Sulfasalazine - Can inhibit folate absorption.
Minor Interactions
- Cholestyramine - Can reduce absorption of fat-soluble vitamins (less relevant for B vitamins) and potentially iron.
- Dietary fiber, phytates (in whole grains, legumes), oxalates (in spinach, rhubarb) - Can reduce iron absorption.
- Calcium supplements - Can reduce iron absorption if taken concurrently.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess for anemia (hemoglobin, hematocrit, MCV) and other blood cell abnormalities.
Timing: Prior to initiation, especially if treating deficiency.
Serum Ferritin, Serum Iron, Total Iron Binding Capacity (TIBC), Transferrin Saturation
Rationale: To assess iron stores and diagnose iron deficiency anemia.
Timing: Prior to initiation, if iron deficiency is suspected.
Serum Vitamin B12, Serum Folate, Methylmalonic Acid (MMA), Homocysteine
Rationale: To assess B12 and folate status and differentiate types of anemia.
Timing: Prior to initiation, if B12/folate deficiency is suspected.
Routine Monitoring
Complete Blood Count (CBC)
Frequency: Every 4-8 weeks initially, then every 3-6 months once stable, or as clinically indicated.
Target: Hemoglobin: Age/sex appropriate normal range; MCV: 80-100 fL
Action Threshold: Failure to improve hemoglobin/hematocrit, persistent microcytosis (if iron deficient), or macrocytosis (if B12/folate deficient) may indicate inadequate dosing, malabsorption, or alternative diagnosis.
Serum Ferritin
Frequency: Every 3-6 months, or as clinically indicated, until iron stores are repleted.
Target: >30-50 ng/mL (for repletion), >100 ng/mL (for functional iron deficiency)
Action Threshold: Persistent low ferritin indicates ongoing iron deficiency or malabsorption. Excessively high ferritin may indicate iron overload.
Serum Vitamin B12, Serum Folate
Frequency: Every 3-6 months, or as clinically indicated, until levels normalize and stabilize.
Target: B12: 200-900 pg/mL; Folate: >4 ng/mL
Action Threshold: Persistent low levels indicate ongoing deficiency or malabsorption.
Symptom Monitoring
- Gastrointestinal upset (nausea, constipation, diarrhea, abdominal pain)
- Dark or black stools (common with iron supplementation, not indicative of bleeding unless tarry/foul-smelling)
- Metallic taste
- Fatigue, weakness, pallor (improvement indicates efficacy)
- Neurological symptoms (if B12 deficient, monitor for improvement or worsening)
Special Patient Groups
Pregnancy
Iron and B vitamin supplementation (especially folic acid and B12) are often recommended or essential during pregnancy to support fetal development and prevent maternal anemia. Folic acid is crucial to prevent neural tube defects. Dosing should be guided by a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Folic acid supplementation is critical before conception and during the first trimester to prevent neural tube defects. Iron needs increase.
Second Trimester:
Iron needs continue to increase significantly due to expanding maternal blood volume and fetal demands.
Third Trimester:
Iron needs remain high. B vitamin supplementation continues to be important for maternal and fetal health.
Lactation
Iron and B vitamins are generally considered safe and often recommended during lactation to support maternal health and ensure adequate nutrient transfer to breast milk. Consult a healthcare provider for appropriate dosing.
Infant Risk:
Low risk at typical supplement doses. Benefits of maternal supplementation generally outweigh risks.
Pediatric Use
Iron overdose is a leading cause of accidental poisoning deaths in young children. Keep all iron-containing products out of reach of children. Dosing must be precise and guided by a pediatrician based on age, weight, and specific deficiency. Liquid formulations are often preferred for younger children.
Geriatric Use
Older adults may have increased risk of B12 deficiency (due to malabsorption, e.g., atrophic gastritis, PPI use) and iron deficiency (due to chronic blood loss, poor diet). Supplementation can be beneficial. Monitor for potential drug interactions and gastrointestinal side effects.
Clinical Information
Clinical Pearls
- Advise patients that iron supplements can cause dark or black stools, which is normal and not a cause for concern unless stools are tarry or foul-smelling, indicating potential bleeding.
- To minimize GI side effects (nausea, constipation), start with a lower dose of iron and gradually increase, or take with a small amount of food (though absorption may be reduced).
- Constipation is a common side effect of iron; recommend increased fluid intake and dietary fiber, or consider a stool softener if needed.
- Emphasize the importance of consistent daily dosing for optimal results, especially when treating anemia.
- Educate patients about potential drug interactions, particularly separating iron from antacids, tetracyclines, fluoroquinolones, and levothyroxine by at least 2-4 hours.
- For B12 deficiency, ensure proper diagnosis (e.g., pernicious anemia) as oral supplementation may not be sufficient if intrinsic factor is lacking.
Alternative Therapies
- Individual iron supplements (e.g., ferrous sulfate, ferrous gluconate, ferrous fumarate)
- Individual B vitamin supplements (e.g., folic acid, vitamin B12, B complex)
- Dietary modifications to increase iron and B vitamin intake
- Intravenous iron (for severe iron deficiency or malabsorption)
- Parenteral vitamin B12 (for severe B12 deficiency or malabsorption)
Cost & Coverage
Average Cost:
Highly variable, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often OTC, may not be covered by insurance unless prescribed for a diagnosed deficiency. Some prescription formulations may be covered as Tier 1 or 2.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.